MHRA (Medicines and Healthcare products Regulatory Agency) guidance addresses growing profile of POC (point-of-care) testing:
This article was originally published in Clinica
Executive Summary
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance highlighting the importance of managing and overseeing point-of-care testing (POCT) on the part of each healthcare provider. The MHRA's Top 10 Tips calls on each hospital to rely on its pathology laboratory for support regarding the procurement, use and safety related to POCT devices. It describes as "vital" the creation by each hospital of a committee dedicated to co-ordinating the "many people involved" in its POCT service and that one person be appointed to manage it. It also raises issues related to the handling and disposal of sharps and reagents and the importance of training, which "must be provided". Quality control and the monitoring of results against the devices used is also essential, says the agency. Providers are urged to ensure that they adhere to manufacturer guidelines on usage and maintenance.